Description of Event or Problem · 1
PATIENT HAD ROUTINE (EVERY TWO MONTHS) TELEPHONE PACEMAKER MONITORING, WHICH REVEALED A MAGNET RATE OF 47.9 BPM. NORMAL WOULD BE 60 BPM BASED ON THE PROGRAMMING OF THIS PACEMAKER. END OF LIFE PARAMETERS IS PROGRAMMED RATE - 20%, WHICH IN THIS CASE EQUALS 48 BPM. COMPLETE EVALUATION OF PACEMAKER IN ELECTROPHYSIOLOGY PACEMAKER CLINIC CONFIRMED END OF LIFE STATUS, PACEMAKER LIFE WAS LESS THAN ONE YEAR, WHICH WAS UNEXPECTED.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. DATE LAST SERVICED: 01-SEP-93. SERVICE PROVIDED BY: INVALID DATA. SERVICE RECORDS AVAILABLE.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED. RESULTS OF EVALUATION: END OF LIFE - PREMATURE, TELEMETRY FAILURE, UNANTICIPATED SHORT TERM COMPLICATION OF PROCEDURE, BATTERY/PACK. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.